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Women's Health Weekly

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Breast Implants



PMA submitted for next-generation silicone gel-filled breast implants



December 30th, 2004

Inamed Corporation (NASDAQ:IMDC) announced on December 6, 2004, two significant events affecting its Breast Aesthetics franchise:

1) it has submitted a premarket approval application (PMA) with the U.S. Food and Drug Administration (FDA) for its "next generation" Bio- Dimensional Cohesive Gel Matrix (Style 410)

breast implants; and

2) it has been notified by the FDA that its supplemental submission for its pending silicone gel-filled breast implants PMA will be reviewed at a tentatively scheduled meeting of the FDA's General and Plastic Surgery Devices Advisory Panel in April 2005.

"[This] announcement...


Source: Women's Health Weekly (2004-12-30)

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